Director of Quality Assurance and Regulatory Affairs Jobs in Bethesda, MD
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
Senior Manager, Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 4 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 4 days ago
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Regulatory Affairs Manager Combination Products
- Washington, DC (6 miles from Bethesda, MD)
- 9 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 9 days ago
HOW MIGHT YOU DEFY IMAGINATION? Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Washington, DC (6 miles from Bethesda, MD)
- 9 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 9 days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Manager Quality Assurance Clinical and Pharmacovigilance (PV)
- Germantown, MD (14 miles from Bethesda, MD)
- 19 days ago
- Germantown, MD (14 miles from Bethesda, MD)
- 19 days ago
Manager Quality Assurance Clinical and Pharmacovigilance (PV) Job Description Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene...
- Washington, DC (6 miles from Bethesda, MD)
- 25 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 25 days ago
The Talent Acquisition department hires qualified candidates to fill positions which contribute to the overall strategic success of Howard University. Hiring staff for fit makes significant...
Director/Senior Director, Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 26 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 26 days ago
Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of subject matter experts Experience...
Manager/Senior Manager, Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 26 days ago
- Washington, DC (6 miles from Bethesda, MD)
- 26 days ago
Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of subject matter experts Experience...
Lab Manager - Georgetown University College of Arts & Sciences Georgetown University
- Washington, DC (6 miles from Bethesda, MD)
- 30+ days ago
- Washington, DC (6 miles from Bethesda, MD)
- 30+ days ago
Lab Manager - Georgetown University College of Arts & Sciences Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the...
Lab Manager - Georgetown University College of Arts & Sciences
- Washington, DC (6 miles from Bethesda, MD)
- 30+ days ago
- Washington, DC (6 miles from Bethesda, MD)
- 30+ days ago
Georgetown University comprises two unique campuses in the nations capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just...
US Strategic Director - Regulatory Affairs
- Washington, DC (6 miles from Bethesda, MD)
- 30+ days ago
- Washington, DC (6 miles from Bethesda, MD)
- 30+ days ago
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe...
Director, Quality Assurance (Compliance)
- Chantilly, VA (19 miles from Bethesda, MD)
- 30+ days ago
- Chantilly, VA (19 miles from Bethesda, MD)
- 30+ days ago
Requirements Reports to Global Quality Head Minimum Experience & Education BA/BS in Biochemistry, Chemistry or related field, MS/MA preferable 13 + years of experience in Quality within the biotech...
- Chantilly, VA (19 miles from Bethesda, MD)
- 45+ days ago
- Chantilly, VA (19 miles from Bethesda, MD)
- 45+ days ago
The Aerospace Corporation is the trusted partner to the nations space programs, solving the hardest problems and providing unmatched technical expertise. As the operator of a federally funded...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Bethesda, MD
- 90+ days ago
- Bethesda, MD
- 90+ days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
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Director of Quality Assurance and Regulatory Affairss in Bethesda, MD offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Quality Assurance and Regulatory Affairs position
- Verbal Communication
- Mentoring
- Quality Systems
- Implementation
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Assay Development
- Biomarkers
- Flow Cytometry
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Genotyping
- Lab Safety
- Next-Generation Sequencing
- Molecular Biology
- Cloning
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Good Laboratory Practice
- Biotechnology
- Clinical Trials
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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